Pharmacovigilance Operations Consultant

Clora; United States; Remote; USD 144,648 - 241,080; Full time

Job summary

A biopharmaceutical company is seeking an experienced Drug Safety / Pharmacovigilance Operations expert to lead the transition of pharmacovigilance operations with a focus on regulatory compliance and vendor performance. The ideal candidate has a strong background in the pharmaceutical industry, with over 5 years of experience in drug safety operations and excellent leadership skills. This role offers the flexibility to work on-site or remotely, contributing to innovative solutions in the mental health space.

Qualifications

• 5+ years in Drug Safety / PV Operations within the pharma or biotech industry.
• In-depth knowledge of GCP, GVP, FDA, EMA, and ICH guidelines.
• Must be detail-oriented with strong organizational skills.

Responsibilities

• Lead the CRO transition management for pharmacovigilance operations.
• Oversee safety database migration and ensure regulatory compliance.
• Establish vendor governance mechanisms and monitor CRO performance.

Skills

Leadership skills

Communication skills

Adaptability

Problem-solving skills

Education

BS or advanced degree in life science, nursing, pharmacy, or healthcare

Tools

Oracle Argus safety database

Microsoft Office applications

Job description

Hourly rate: $105 - $175/hour (based on experience & seniority level)

About

We are a biopharmaceutical company aiming to revolutionize the mental health space. We are seeking an experienced Drug Safety / Pharmacovigilance Operations expert to lead preparations for an upcoming Phase 3 program and PV database vendor transition from the old CRO to new CRO.

Responsibilities

• CRO Transition Management: Lead the end-to-end transition of pharmacovigilance operations from the incumbent CRO to the new CRO partner, including project planning, timeline development, risk assessment, and issue resolution throughout the migration process.
• CRO Transition Project Plan Deliverable: Comprehensive project plan detailing the timeline, milestones, responsibilities, dependencies, and risk mitigation strategies for the pharmacovigilance CRO transition.
• Safety Database Migration Oversight: Provide strategic oversight of the safety database transfer, including data mapping, migration validation, reconciliation activities, and user acceptance testing to ensure data integrity and regulatory compliance.
• Database Migration Validation Report Deliverable: Documentation of the safety database migration process, including data mapping specifications, reconciliation results, validation test scripts and outcomes, and confirmation of data integrity post-migration.
• Vendor Performance Governance: Establish and oversee vendor governance mechanisms, including definition of key performance indicators (KPIs), metrics dashboards, and regular oversight meetings to monitor CRO compliance and operational performance.
• CRO Governance Framework Deliverable: Documented governance structure defining oversight committee composition, meeting cadence, escalation pathways, decision-making authority, and communication protocols between sponsor and CRO.
• Regulatory Compliance Advisory: Provide expert guidance on global pharmacovigilance regulatory requirements (FDA, EMA, MHRA, ICH) to ensure the new CRO setup and safety database configuration meet all applicable standards for current and planned clinical programs.
• Regulatory Compliance Gap Assessment Deliverable: Report identifying any gaps between current/planned PV operations and applicable regulatory requirements (FDA, EMA, MHRA, ICH GVP), with prioritized
• Inspection Readiness Consulting: Assess organizational readiness for pharmacovigilance regulatory inspections, identify gaps, and advise on remediation strategies to ensure the Company and its CRO partner are inspection-ready.
• Study-Specific PV Setup Documentation Deliverable: Configuration specifications and operational readiness documentation for upcoming clinical studies, including safety database setup requirements, reporting configurations, and CRO task assignments.

Ideal Candidate

• BS or advanced degree preferably in life science, nursing, pharmacy or other healthcare related profession (RN, PharmD, NP, PhD, MPH, MD, etc.)
• At least 5+ years working in Drug Safety / PV Operations within the pharmaceutical or biotechnology industry with in-depth knowledge of Good Clinical Practice (GCP); GVP; ICH guidelines; FDA, EMA, and other international regulations and guidelines; clinical trial conduct, and process and quality management.
• Strong leadership and management skills, with a track record of building and developing high-performing teams
• Experience overseeing and managing Drug Safety / PV vendors
• Previous experience with safety database programs such as Oracle Argus
• Strong interpersonal and communication skills (both written and oral)
• Self-motivated and adaptable in a dynamic, nimble, start-up environment
• Detail-oriented, with good organizational, and time management proficiencies. Must be able to work on multiple projects simultaneously
• Demonstrated and creative problem solving skills (including taking ownership to ensure timely resolution) and the ability to successfully execute in an environment under time and resource pressures
• Ability to establish priorities, excellent sense of urgency and a strong desire to collaborate (self-aware, effective relationship management and interpersonal skills)
• Strong computer skills and experience using Microsoft Office applications
• Ability to work on-site or remotely and attend in-person meetings
• Ability to work cross culturally and with a variety of time zones